Pfizer Inc said that early results from a major clinical trial showed that patients receiving a treatment regimen based on its calcium channel blocker, Norvasc (amlodipine besylate) experienced favourable cardiovascular benefits.

Funded by Pfizer, ASCOT is an investigator-initiated trial coordinated by an independent steering committee. The study began in 1998 and enrolled patients in the United Kingdom, Ireland, Sweden, Norway, Denmark, Finland and Iceland.

Involving nearly 20,000 patients with high blood pressure, the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was designed to compare the effects of a Norvasc-based regimen versus a standard beta blocker-based regimen in reducing cardiac events in patients with hypertension and multiple cardiovascular risk factors. As a result of the favourable benefits demonstrated by patients in the Norvasc-based regimen, the independent ASCOT steering committee has decided to stop the trial early so that ASCOT investigators and patients can discuss their optimum hypertension treatment moving forward.

"The early stopping of this trial clearly confirms the benefits of blood-pressure lowering with a Norvasc-based treatment regimen for hypertensive patients who have additional cardiovascular risk factors," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "This new information, along with the long-term results from the ALLHAT, VALUE and CAMELOT clinical studies further strengthens Norvasc's clinical evidence and underscores that a Norvasc-based regimen may represent optimal care for hypertensive patients," Dr Joseph added.

In addition to treatment for high blood pressure, a sub-set of patients in ASCOT who also had normal or slightly elevated cholesterol levels, and usually not considered for lipid lowering treatment, received Lipitor (atorvastatin calcium) or placebo to evaluate the cardiovascular benefits of lowering cholesterol levels regardless of their cholesterol levels. In October 2002, the lipid-lowering arm of ASCOT was also stopped earlier than expected due to a significant benefit in the reduction of heart attacks and stroke in Lipitor-treated patients.

"ASCOT highlights that these hypertensive patients may benefit from a treatment regimen including both Norvasc and Lipitor. With Caduet, physicians now have the option to offer patients a single therapy regimen," Dr. Feczko said adding, "We look forward to receiving the fully analyzed results."

Since its introduction fourteen years ago, the safety and efficacy of Norvasc has been supported through an extensive clinical trial program with about 400 completed trials involving more than 600,000 patients.

Norvasc is indicated for high blood pressure and angina. In clinical trials, the most common side effects for Norvasc versus placebo were edema, headache, fatigue and dizziness.